Recognized Consensus Standards: Medical Devices
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Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 05/25/2026 | Dental/ ENT |
4-375 | Complete | ANSI ADA | Standard No. 197-2021 | Spoons and Bone Curettes in Dentistry |
| 05/25/2026 | Dental/ ENT |
4-391 | Complete | ISO | 16498 First edition 2013-07 | Dentistry - Minimal dental implant data set for clinical use |
| ANSI ADA | Standard No. 172-2019 | Minimal Dental Implant Data Set for Clinical Use | ||||
| 08/06/2013 | Dental/ ENT |
4-204 | Complete | ANSI ASA | S3.42-2012/Part 2/ IEC 60118-15:2012 (R2025) | American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard) |
| 01/27/2015 | Dental/ ENT |
4-185 | Complete | ANSI ASA | S3.45-2009 (Reaffirmed 2024) | American National Standard Procedures for Testing Basic Vestibular Function |
| 07/09/2014 | Dental/ ENT |
4-211 | Complete | ANSI ASA | S3.46-2013 (Reaffirmed 2023) | American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids |
| 12/22/2025 | Dental/ ENT |
4-355 | Complete | ISO | 18397 Second edition 2025-07 | Dentistry - Powered scaler |
| 01/14/2019 | Dental/ ENT |
4-252 | Complete | ISO | 10650 Second edition 2018-08 | Dentistry - Powered polymerization activators |
| ANSI ADA | Standard No. 48-2020 | Curing Lights (Powered Polymerization Activators) | ||||
| 01/14/2019 | Dental/ ENT |
4-250 | Complete | ISO | 7494-1 Third edition 2018-06 | Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements |
| 08/14/2015 | Dental/ ENT |
4-130 | Complete | ANSI ADA | Standard No. 17-1983 (R2014) | Denture Base Temporary Relining Resins |
| 07/09/2014 | Dental/ ENT |
4-165 | Complete | ANSI ASA | S3.13-1987 (Reaffirmed 2024) | American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
| 09/09/2008 | Dental/ ENT |
4-145 | Complete | ISO | 22803 First edition 2004-09-01 | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file |
| 12/18/2023 | Dental/ ENT |
4-312 | Complete | ANSI ASA | S3.35-2021 | American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions |
| 12/22/2025 | Dental/ ENT |
4-353 | Complete | ISO | 20127 Third edition 2025-05 | Dentistry - Physical properties of powered toothbrushes |
| 12/18/2023 | Dental/ ENT |
4-316 | Complete | ISO | 20127 Second edition 2020-08 | Dentistry - Physical properties of powered toothbrushes |
| ANSI ADA | Standard No.120-2022 | Dentistry - Physical Properties of Powered Toothbrushes | ||||
| 07/09/2014 | Dental/ ENT |
4-177 | Complete | ANSI ASA | S12.65-2006 (Reaffirmed 2025) | American National Standard For Rating Noise with Respect to Speech Interference |
| 01/14/2019 | Dental/ ENT |
4-162 | Complete | ANSI ASA | S3.4-2007 (Reaffirmed 2025) | American National Standard Procedure for the Computation of Loudness of Steady Sounds |
| 05/25/2026 | Dental/ ENT |
4-399 | Complete | ANSI ADA | Standard No. 182-2021 | Test Method for the Bonding Test Between Polymer Teeth and Denture Base Polymer |
| ISO | TS 19736 First edition 2017-09 | Dentistry - Bonding test between polymer teeth and denture base materials | ||||
| 05/25/2026 | Dental/ ENT |
4-386 | Complete | ISO | 13397-3 First edition 1996-09 | Periodontal curettes, dental scalers and excavators - Part 3: Dental scalers - H-type |
| 05/25/2026 | Dental/ ENT |
4-387 | Complete | ISO | 13397-5 First edition 2015-09 | Dentistry - Periodontal curettes, dental scalers and excavators - Part 5: Jacquette scalers |
| 12/23/2019 | Dental/ ENT |
4-261 | Complete | ISO | 7405 Third edition 2018-10 Corrected version 2018-12 | Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
| 12/23/2019 | Dental/ ENT |
4-262 | Complete | IEC | 80601-2-60 Edition 2.0 2019-06 | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| 08/21/2017 | Dental/ ENT |
4-233 | Complete | ISO | 20795-2 Second edition 2013-03-01 | Dentistry - Base polymers - Part 2: Orthodontic base polymers |
| 07/06/2020 | Dental/ ENT |
4-263 | Complete | ISO | 9693 Third edition 2019-10 | Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
| ANSI ADA | Standard No. 38-2020 | Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems | ||||
| 05/25/2026 | Dental/ ENT |
4-384 | Complete | ISO | 13397-1 First edition 1995-12 | Periodontal curettes, dental scalers and excavators - Part 1: General requirements |
| 07/15/2019 | Dental/ ENT |
4-258 | Complete | ISO | 10139-2 Third edition 2016-06-15 | Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use |
| ANSI ADA | Standard No. 160-2020 | Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use | ||||
| 12/21/2020 | Dental/ ENT |
4-268 | Complete | ISO | 15841 Second edition 2014-08 | Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)] |
| ANSI ADA | Standard No. 32-2017 | Orthodontic Wires | ||||
| 01/14/2019 | Dental/ ENT |
4-256 | Complete | ANSI ADA | Standard No. 132-2015 | Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
| 06/07/2021 | Dental/ ENT |
4-281 | Complete | ISO | 1797 Third Edition 2017-05 | Dentistry - Shanks for rotary and oscillating instruments |
| ANSI ADA | Standard No. 179-2020 | Shanks for Rotary and Oscillating Instruments | ||||
| 05/25/2026 | Dental/ ENT |
4-397 | Complete | ISO | 23298 First edition 2023-05 | Dentistry - Test methods for machining accuracy of computer-aided milling machines |
| 05/25/2026 | Dental/ ENT |
4-370 | Complete | ANSI ADA | Standard No. 126-2015 (R2023) | Casting Investments and Refractory Die Materials |
| 05/25/2026 | Dental/ ENT |
4-371 | Complete | ANSI ADA | Standard No. 135-2015 (R2020) | Denture Adhesives |
| 12/21/2020 | Dental/ ENT |
4-265 | Complete | ISO | 10271 Third edition 2020-08 | Dentistry - Corrosion test methods for metallic materials |
| ANSI ADA | Standard No. 97-2020 | Corrosion Test Methods for Metallic Materials | ||||
| 07/09/2014 | Dental/ ENT |
4-160 | Complete | ANSI ASA | S3.1-1999 (Reaffirmed 2023) | American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms |
| 08/14/2015 | Dental/ ENT |
4-220 | Complete | ANSI ASA | S3.22-2014 (Reaffirmed 2020) | American National Standard Specification of Hearing Aid Characteristics |
| 08/14/2015 | Dental/ ENT |
4-184 | Complete | ANSI ASA | S3.25-2009 (Reaffirmed 2024) | American National Standard For an Occluded Ear Simulator |
| 05/29/2023 | Dental/ ENT |
4-301 | Complete | ISO | 21563 Second edition 2021-08 | Dentistry - Hydrocolloid impression materials |
| ANSI ADA | Standard No. 128-2022 | Hydrocolloid Impression Materials | ||||
| 12/22/2025 | Dental/ ENT |
4-356 | Complete | ANSI ADA | Standard No. 32-2024 | Dentistry - Orthodontic Wires |
| 05/26/2025 | Dental/ ENT |
4-342 | Complete | ANSI ADA | Standard No. 47-2-2021 | Stationary Dental Units and Patient Chairs-Part 2: Air, Water, Suction and Wastewater Systems |
| 05/29/2023 | Dental/ ENT |
4-300 | Complete | ISO | 22674 Third edition 2022-08 | Dentistry - Metallic materials for fixed and removable restorations and appliances |
| ANSI ADA | Standard No. 134-2023 | Dentistry - Metallic Materials for Fixed and Removable Restorations and Appliances | ||||
| 05/25/2026 | Dental/ ENT |
4-372 | Complete | ANSI ADA | Standard No. 141-2013 (R2023) | Dentistry-Dental Duplicating Material |
| 05/25/2026 | Dental/ ENT |
4-390 | Complete | ISO | 15912 Second edition 2016-01 | Dentistry - Refractory investment and die material |
| 12/18/2023 | Dental/ ENT |
4-321 | Complete | ISO | 23450 First edition 2021-03 | Dentistry - Intraoral camera |
| ANSI ADA | Standard No. 213-2024 | Dentistry - Intra Oral Camera | ||||
| 01/14/2019 | Dental/ ENT |
4-217 | Complete | ANSI ASA | S3.36-2012 (Reaffirmed 2022) | American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements |
| 01/14/2019 | Dental/ ENT |
4-171 | Complete | ANSI ASA | S3.37-1987 (Reaffirmed 2025) | American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids |
| 12/18/2023 | Dental/ ENT |
4-317 | Complete | ISO | 8325 Third edition 2023-03 | Dentistry - Test methods for rotary instruments |
| ANSI ADA | Standard No. 180-2024 | Dentistry - Test Methods for Rotary Instruments | ||||
| 12/18/2023 | Dental/ ENT |
4-318 | Complete | ISO | 20749 Second edition 2023-06 | Dentistry - Pre-capsulated dental amalgam |
| ANSI ADA | Standard No.144-2025 | Dentistry - Pre-capsulated Dental Amalgam | ||||
| 12/18/2023 | Dental/ ENT |
4-315 | Complete | ISO | 24234 Third edition 2021-08 | Dentistry - Dental Amalgam |
| 12/18/2023 | Dental/ ENT |
4-310 | Complete | ISO | 22112 Second edition 2017-08 | Dentistry - Artificial teeth for dental prostheses |
| ANSI ADA | Standard No. 15-2021 | Artificial Teeth for Dental Prostheses | ||||
| 12/18/2023 | Dental/ ENT |
4-320 | Complete | ISO | 13402 First edition 1995-08-01 | Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure |
| 12/22/2025 | Dental/ ENT |
4-352 | Complete | ANSI ASA | S3.35-2025 | American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions |
| 12/23/2024 | Dental/ ENT |
4-335 | Complete | ISO | 11499 Third edition 2014-06 | Dentistry - Single-use cartridges for local anaesthetics |
| ANSI ADA | Standard No. 190-2020 | Single-Use Dental Cartridges for Local Anesthetics | ||||
| 12/23/2024 | Dental/ ENT |
4-337 | Complete | ISO | 20608 First edition 2018-04 | Dentistry - Powder jet handpieces and powders |
| ANSI ADA | Standard No. 212-2024 | Dentistry - Powder Jet Handpieces and Powders | ||||
| 12/23/2024 | Dental/ ENT |
4-338 | Complete | ISO | 22683 First edition 2022-05 | Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems |
| 06/07/2021 | Dental/ ENT |
4-275 | Complete | ANSI ASA | S3.6-2018 (Reaffirmed 2023) | American National Standard Specification for Audiometers |
| 12/22/2025 | Dental/ ENT |
4-351 | Complete | ISO | 6877 Fourth edition 2025-08 | Dentistry - Endodontic obturating materials |
| 12/18/2023 | Dental/ ENT |
4-309 | Complete | ISO | 6877 Third edition 2021-09 | Dentistry - Endodontic obturating materials |
| ANSI ADA | Standard No. 78-2022 | Dentistry - Endodontic Obturating Materials | ||||
| 05/25/2026 | Dental/ ENT |
4-368 | Complete | ISO | 4823 Sixth edition 2025-06 | Dentistry - Elastomeric impression and bite registration materials |
| 06/07/2021 | Dental/ ENT |
4-278 | Complete | ISO | 4823 Fifth edition 2021-02 | Dentistry - Elastomeric impression and bite registration materials |
| ANSI ADA | Standard No. 19-2022 | Elastomeric Impression and Bite Registration | ||||
| 12/18/2023 | Dental/ ENT |
4-311 | Complete | ISO | 9917-2 Third edition 2017-09 | Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 12/18/2023 | Dental/ ENT |
4-313 | Complete | ISO | 27020 Second edition 2019-06 | Dentistry - Brackets and tubes for use in orthodontics |
| ANSI ADA | Standard No.100-2020 | Orthodontic Brackets and Tubes | ||||
| 12/20/2021 | Dental/ ENT |
4-291 | Complete | ISO | 28399 First edition 2011-01 | Dentistry - Products for external tooth bleaching |
| ANSI ADA | Standard No. 136-2015 (R2020) | Products for External Tooth Bleaching | ||||
| 12/22/2025 | Dental/ ENT |
4-364 | Complete | ISO | 3990 First edition 2023-07 | Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials |
| 05/29/2023 | Dental/ ENT |
4-307 | Complete | ISO | 13504 First edition 2012-07 | Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment |
| 05/29/2023 | Dental/ ENT |
4-308 | Complete | ISO | 14708-7 Second edition 2019-12 | Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems |
| 05/29/2023 | Dental/ ENT |
4-303 | Complete | ISO | 9333 Third edition 2022-08 | Dentistry - Brazing materials |
| ANSI ADA | Standard No. 88-2024 | Dentistry - Dental Brazing Materials | ||||
| 08/21/2017 | Dental/ ENT |
4-232 | Complete | ISO | 20795-1 Second edition 2013-03-01 | Dentistry - Base polymers - Part 1: Denture base polymers |
| 12/20/2021 | Dental/ ENT |
4-285 | Complete | ANSI ADA | Standard No. 37-1986 (R2020) | Dental Abrasive Powders |
| 12/19/2022 | Dental/ ENT |
4-294 | Complete | ANSI ADA | Standard No. 139-2020 | Dental Base Polymers |
| 12/19/2022 | Dental/ ENT |
4-295 | Complete | ANSI ADA | Standard No. 41-2020 | Evaluation of Biocompatibility of Medical Devices Used in Dentistry |
| 06/07/2021 | Dental/ ENT |
4-273 | Complete | ANSI ASA | S3.7-2016 (Reaffirmed 2025) | American National Standard Method for Coupler Calibration of Earphones |
| 06/07/2021 | Dental/ ENT |
4-279 | Complete | ANSI ADA | Standard No. 85-2004 (R2009) | Part 1: Disposable Prophy Angles |
| 06/07/2021 | Dental/ ENT |
4-283 | Complete | ISO | 16409 Second edition 2016-10 | Dentistry - Oral care products - Manual interdental brushes |
| ANSI ADA | Standard No. 125-2018 | Manual Interdental Brushes | ||||
| 12/22/2025 | Dental/ ENT |
4-365 | Complete | ISO | 6873 Third edition 2013-04 | Dentistry - Gypsum products |
| ANSI ADA | Standards No. 25-2015 (R2021) | Dental Gypsum Products | ||||
| 12/22/2025 | Dental/ ENT |
4-366 | Complete | ISO | 7551 Second edition 2023-05 | Dentistry - Endodontic absorbent points |
| ANSI ADA | Standard No. 73-2024 | Dentistry - Endodontic Absorbent Points | ||||
| 12/22/2025 | Dental/ ENT |
4-367 | Complete | ISO | 9997 Third edition 2020-01 | Dentistry - Cartridge Syringes |
| 12/19/2022 | Dental/ ENT |
4-297 | Complete | ISO | 20126 Third edition 2022-03 | Dentistry - Manual toothbrushes - General requirements and test methods |
| 12/20/2021 | Dental/ ENT |
4-287 | Complete | ANSI ADA | Standard No. 116-2020 | Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses) |
| 05/25/2026 | Dental/ ENT |
4-394 | Complete | ISO | 21672-1 First edition 2012-04 | Dentistry - Periodontal probes - Part 1: General requirements |
| ANSI ADA | Standard No. 169-2019 | Periodontal Probes: General Requirements | ||||
| 05/25/2026 | Dental/ ENT |
4-395 | Complete | ISO | 21850-1 First edition 2020-04 | Dentistry - Materials for dental instruments - Part 1: Stainless steel |
| ANSI ADA | Standard No. 196-2021 | Materials for Dental Instruments - Part 1: Stainless Steel | ||||
| 05/25/2026 | Dental/ ENT |
4-396 | Complete | ISO | 22570 First edition 2020-02 | Dentistry - Spoons and bone curettes |
| 05/26/2025 | Dental/ ENT |
4-339 | Complete | ANSI ADA | Standard No. 119-2023 | Dentistry-Manual Toothbrushes |
| 05/30/2022 | Dental/ ENT |
4-293 | Complete | ANSI ADA | Standard No. 119-2021 | Manual Toothbrushes |
| 05/26/2025 | Dental/ ENT |
4-343 | Complete | ANSI ADA | Standard No. 105-2024 | Elastomeric Auxiliaries for Use in Orthodontics |
| 12/22/2025 | Dental/ ENT |
4-358 | Complete | ANSI ADA | Standard No. 95-2020 | Endodontics Instruments - Enlargers |
| 12/22/2025 | Dental/ ENT |
4-359 | Complete | ANSI ADA | Standard No. 159-2024 | Dentistry - Coiled Springs for Use in Orthodontics |
| 12/22/2025 | Dental/ ENT |
4-360 | Complete | ISO | 3630-1 Third edition 2019-08 | Dentistry - Endodontic instruments - Part 1: General requirements |
| ANSI ADA | Standard No. 101-2021 | Endodontic Instruments - General Requirements | ||||
| 12/22/2025 | Dental/ ENT |
4-361 | Complete | ISO | 3630-2 Fourth edition 2023-02 | Dentistry - Endodontic instruments - Part 2: Enlargers |
| ANSI ADA | Standard No. 101-2-2025 | Dentistry - Endodontic Instruments - Part 2: Enlargers | ||||
| 05/26/2025 | Dental/ ENT |
4-344 | Complete | ANSI ADA | Standard No. 186-2024 | Dentistry - Polymer-based Machinable Blanks |
| 01/14/2019 | Dental/ ENT |
4-254 | Complete | ANSI ADA | Standard No. 99-2001 (R2023) | Athletic Mouth Protectors and Materials |
| 05/26/2025 | Dental/ ENT |
4-345 | Complete | ANSI ADA | Standard No. 187-2024 | Dentistry - Dental CAD/CAM Machinable Ceramic Blanks |
| 05/26/2025 | Dental/ ENT |
4-346 | Complete | ISO | 9680 Fourth edition 2021-11 | Dentistry - Operating lights |
| ANSI ADA | Standard No. 89-2023 | Dentistry - Dental Operating Lights | ||||
| 05/26/2025 | Dental/ ENT |
4-347 | Complete | ISO | 22254 First edition 2005-08 | Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection |
| 12/22/2025 | Dental/ ENT |
4-362 | Complete | ISO | 3630-3 Third edition 2021-06 Corrected version 2023-05 | Dentistry - Endodontic instruments - Part 3: Compactors |
| ANSI ADA | Standard No. 101-3-2025 | Dentistry - Endodontic Instruments - Part 3: Compactors | ||||
| 12/22/2025 | Dental/ ENT |
4-363 | Complete | ISO | 3630-5 Second edition 2020-08 | Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments |
| ANSI ADA | Standard No. 28-2021 | Endodontic Instruments - Shaping and Cleaning Instruments | ||||
| 05/25/2026 | Dental/ ENT |
4-389 | Complete | ISO | 15098 Second edition 2024-07 | Dentistry - Dental tweezers |
| 12/21/2020 | Dental/ ENT |
4-269 | Complete | ISO | 3964 Third edition 11-2016 | Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)] |
| ANSI ADA | Standard No. 158-2020 | Coupling Dimensions for Dental Handpiece Connectors | ||||
| 05/25/2026 | Dental/ ENT |
4-378 | Complete | ISO | 9173-2 First edition 2010-05 | Dentistry - Extraction forceps - Part 2: Designation |
| 05/25/2026 | Dental/ ENT |
4-379 | Complete | ISO | 9173-3 First edition 2014-05 | Dentistry - Extraction forceps - Part 3: Design |
| 05/25/2026 | Dental/ ENT |
4-380 | Complete | ISO | 13017 Second edition 2020-07 | Dentistry - Magnetic attachments |
| ANSI ADA | Standard No. 201-2022 | Dentistry - Magnetic Attachments | ||||
| 05/25/2026 | Dental/ ENT |
4-381 | Complete | ISO | 13078 First edition 2013-02 | Dentistry - Dental furnace - Test method for temperature measurement with separate thermocouple |
| ANSI ADA | Standard No.163-2018 | Dental Furnance, Part 1: Test Method for Temperature Measurement with Separate Thermocouple | ||||
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